Apparatus and method for suturing a tissue

ABSTRACT

An apparatus for suturing a tissue. The apparatus includes an outer tube, a thread threaded in the outer tube and at least one anchoring element located inside the outer tube and configured to be inserted into the tissue from an outlet end of the outer tube. The outer tube is configured to freely accommodate the thread and the at least one anchoring element, and the anchoring element includes a body adapted to be threaded on the thread and having at least locking element for locking the thread to the anchoring element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/091,613, filed Apr. 6, 2016, which is a continuation of PCT PatentApplication No. PCT/IL2015/050599, filed on Jun. 14, 2015, which claimsthe benefit of priority to U.S. Provisional Patent Application No.62/012,363, filed on Jun. 15, 2014, all of which are incorporated hereinby reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention relates to a device for suturing tissue and, moreparticularly, to an apparatus and device capable of threading acontinuous or single adjusted length and depth of suture through atissue and to a method of using same to approximate, ligate, suture orfixate tissue and/or an implant such as a mesh.

Suturing remains a common approach for repair of tissues and is used fortissue approximation, ligation and fixation of tissue access sites,organs, vessels, fixation of meshes and other implants or devices andthe like. Although largely dependent on the skill of the surgeon, theresults obtained using a suture are highly predictable and reliable.

Alternatives to suturing developed over the years such as staples,fasteners (tackers), anchors and tissue adhesives, have gained varyingdegrees of acceptance and are used for tissue repair in both open andminimally invasive procedures. Nonetheless, suturing remains ubiquitousin surgical repair due to availability of a wide variety of suturingkits at relatively low costs and the mechanical advantages afforded bysuturing.

Thus, suture remains a mainstay of surgical repair however, it is notwithout disadvantages. Placing a number of stitches can be tiring andtime-consuming which can lead to suturing errors that can compromise theintegrity of repair. In addition, manipulation of a suture needle aswell as access to the suturing location can be difficult especially inminimally invasive surgery due to the nature of the minimally invasivesurgery and/or the limited anatomical space around the target tissues,while tying knots with a desired amount of tension requires precisemanipulation of the suture ends further complicating and slowing open,and in particular, minimally-invasive surgeries. In fact, for manyprocedures the time spent suturing may be significantly greater than thetime spent treating the underlying target tissues.

Although tissue stapling devices and adhesives as well as devices whichemploy a combination of anchors and sutures can traverse theselimitations of suturing by enabling rapid ligation of tissue, the tissueligation/fixation created thereby is oftentimes less reliable or doesnot involve easy access and large number of sutures.

Thus, there remains a need for a device capable of ligating/fixatingtissues rapidly and reliably while being operable within a confinedanatomical space through a minimally invasive approach.

SUMMARY OF THE INVENTION

Some embodiments of the invention may be related to an apparatus forsuturing a tissue. The apparatus may include an outer tube, a threadthreaded in the outer tube and at least one anchoring element locatedinside the outer tube and configured to be inserted into the tissue froman outlet end of the outer tube. The outer tube may be configured tofreely accommodate the thread and the at least one anchoring element,and the anchoring element may include a central elongated body adaptedto be threaded on the thread and having at least one recess, the recesshaving a wide end and a narrow end, the narrow end is for gripping thethread during suturing of the tissue.

Some additional embodiments of the invention may be related to aninsertion device for inserting a thread and one or more anchoringelements into a tissue. The insertion device may include: an outer tube,a thread guide tube for guiding a thread inserted in the thread guidetube. The outer tube may be configured to freely accommodate the threadguide tube and one or more anchoring elements threaded on the threadguide tube such that each anchoring element can slid along the outertube to be exit from an outlet end of the outer tube.

Some embodiments of the present invention may include an anchoringelement for anchoring a suture in a tissue including a central elongatedbody adapted to be threaded on a thread and having at least one recess,the recess having a wide end and a narrow end, the narrow end is to gripthe thread during anchoring.

Some embodiments of the invention may be related to a method of suturinga tissue. The method may include piercing the tissue while inserting tothe tissue an apparatus for suturing, the apparatus may include an outertube, a thread inserted in the outer tube and at least one anchoringelement located inside the outer tube, threaded on the thread andconfigured to be inserted into the tissue from an outlet end of theouter tube, wherein the anchoring element comprises a central elongatedbody adapted to be threaded on the thread and having at least onerecess, the recess having a wide end and a narrow end, the narrow end togripping the thread during suturing of the tissue. The method mayfurther include advancing the at least one anchoring element towards theoutlet end of the outer tube to cause the at least one anchoring elementto exit from the outlet end of the outer tube into the tissue such thatthe at least one anchoring element is anchored in the tissue andthreaded on the thread and causing the thread to be gripped at thenarrow end of the recess of the anchoring element.

Some embodiments of the present invention may include a deviceincluding: (a) an elongated shaft; (b) a plurality of anchor elementsand a suture co-axially disposed along the elongated shaft; and (c) ahandle attached to a proximal end of the shaft, the handle being foractuating release of an anchor element attached to a portion of thesuture from a distal end of the shaft.

According to further embodiments of the invention described below, theanchor element may be hollow with the portion of the suture threadedthere-through.

In some embodiments, the plurality of anchor elements may be concentricwith the suture.

In some embodiments, the plurality of anchor elements and the suture maybe disposed within a lumen of the elongated shaft.

In some embodiments, the device may further include at least one of:mechanism for advancing the anchor element and the suture in a directionof the distal end.

In some embodiments, the anchor element may attach and/or lock to theportion of the suture when the anchor element is released from thedistal end.

In some embodiments, a wall of the anchor element may include at leastone longitudinal slot for trapping the portion of the suture when theanchor element is advanced in the direction of the distal end.

In some embodiments, the portion of the suture may loop through theanchor element.

In some embodiments, the device may be capable of positioning aplurality of contiguous loops of the suture each may have a dedicatedanchor element threaded thereon through a tissue wall.

In some embodiments, a length of the portion of the suture released fromthe distal end may be adjustable.

In some embodiments, the distal end of the shaft may be configured forpiercing through a tissue.

In some embodiments, the anchor element may be configured for piercingthrough a tissue.

In some embodiments, the device may further include a first tubedisposed within the lumen, wherein the plurality of anchor elements maybe disposed around the first tube and the suture may be disposed withinthe first tube.

According to still further embodiments, the device may further include asecond tube disposed within the lumen and around the plurality ofanchors.

According to still further embodiments, the second tube may include atissue piercing distal end.

According to still further embodiments, the device further may include amechanism for advancing the second tube and the anchor element in adirection of the distal end of the shaft.

In some embodiments, the device may further include a suture cuttingelement in or on the shaft.

In some embodiments, the mechanism for advancing the second tube and theanchor element may be actuatable from the handle.

In some embodiments, the mechanism for advancing the second tube and theanchor element may be capable of retracting the second tube.

In some embodiments, the suture cutting element may be actuatable fromthe handle.

Embodiments of the invention may be directed to a tissue suturing devicethat may include: (a) an elongated hollow shaft surrounding a firstco-axial tube and a second coaxial tube having a tissue piercing end;(b) a suture disposed within the first tube; (c) a plurality ofanchoring elements disposed around the first tube and within the secondtube; and (d) a handle attached to a proximal end of the shaft, thehandle may be for actuating a mechanism for advancing and retracting thesecond tube and an anchor element in a direction of a distal end of thehollow shaft so as may enable the anchor element to grab the suture andform a loop of the suture attached to the anchor element when releasedthe distal end of the shaft.

Some embodiments of the present invention may be related to a method ofsuturing tissue. Embodiments of the method may include: (a) providing atissue suturing device having an elongated shaft and plurality of anchorelements and a suture co-axially disposed along the elongated shaft; (b)positioning a distal end of the elongated shaft through an opening inthe tissue; and (c) actuating release of an anchor element attached to aloop of the suture from the distal end of the shaft.

In some embodiments, the method may further include (d) retracting thedistal end of the elongated shaft from the opening in the tissue tothereby juxtapose the anchor element against an internal surface of thetissue and pull strands of the suture loop out of the opening.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter regarded as the invention is particularly pointed outand distinctly claimed in the concluding portion of the specification.The invention, however, both as to organization and method of operation,together with objects, features, and advantages thereof, may best beunderstood by reference to the following detailed description when readwith the accompanying drawings in which:

FIG. 1 is an illustration of a side view of an exemplary apparatus forsuturing a tissue according to some embodiments of the presentinvention;

FIGS. 2A-2C are isometric illustrations of cutaway views of the distalportion of the exemplary apparatus of FIG. 1 according to someembodiments of the invention;

FIGS. 3A-3B are isometric illustrations of exemplary anchoring elementswith a suture loop according to embodiments of the invention;

FIGS. 3C-3I are isometric illustrations of anchoring elements accordingto some embodiments of the invention;

FIGS. 4A-4J are illustrations of several steps of the suture-deliverydistal end of the apparatus of FIG. 1, according to some embodiments ofthe invention;

FIG. 5A is an illustration of several contiguous suture loops withattached anchoring elements positioned through a tissue according tosome embodiments of the invention;

FIG. 5B is an illustration of magnified view of one thread loop andattached anchoring element positioned through the tissue according tosome embodiments of the invention;

FIG. 5C is an illustration of a thread loop with attached bio-absorbableanchoring element (shown partially absorbed) positioned in a tissueaccording to some embodiments of the invention;

FIGS. 6A-6B are illustrations of an embodiment of a mechanism for threadholding and cutting according to some embodiments of the invention;

FIGS. 7A-7D are illustrations of a handle of the apparatus of FIG. 1,showing the anchoring element pusher mechanism and tissue piercing tube(Fig.7A-7B) and the handle mechanism in normal mode (FIG. 7C) andactuated mode (FIG. 7D) according to some embodiments of the invention;

FIGS. 7E-7F are illustrations of the apparatus of FIG. 1 with a flexibleinsertion device (FIG. 7E) or deflectable insertion device (FIG. 7F)according to some embodiments of the invention;

FIG. 8A depicts photographs of components useable for assembling anapparatus according to some embodiments of the invention;

FIGS. 8B-8C are photographs of a delivery of an anchored suture througha foam board (FIG. 8B) and the running stitch created by sequentiallydelivering several anchoring elements from a prototype assembled fromthe components shown in FIG. 8a , according to some embodiments of theinvention;

FIGS. 9A-9B are photographs of two anchoring sites created using theapparatus for suturing a tissue (FIG. 9A) and testing of the loadcapacity of a single anchoring site (FIG. 9B), according to someembodiments of the invention;

FIGS. 10A-10H are illustrations of various steps in the delivery orinsertion of an anchoring element into a tissue using the device ofFIGS. 2A-2C, according to some embodiments of the invention;

FIGS. 11A-11B are illustrations of a device for suturing a tissuecomprising a plurality of anchoring elements according to someembodiments of the invention; and

FIG. 12 is a flowchart of a method of suturing a tissue according tosome embodiments of the invention.

It will be appreciated that for simplicity and clarity of illustration,elements shown in the figures have not necessarily been drawn to scale.For example, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity. Further, where consideredappropriate, reference numerals may be repeated among the figures toindicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

In the following detailed description, numerous specific details are setforth in order to provide a thorough understanding of the invention.However, it will be understood by those skilled in the art that thepresent invention may be practiced without these specific details. Inother instances, well-known methods, procedures, and components have notbeen described in detail so as not to obscure the present invention.

Some embodiments of the present invention may be related to an apparatusfor suturing or fixating a tissue. The tissue may soft or hard tissue.Such apparatus may include three (3) main components, a thread, one ormore anchoring elements for anchoring the thread in the tissue and aninsertion device for inserting the thread and anchoring elements intothe tissue. Such a tissue suturing device which may be used toapproximate, suture, ligate, and fixate tissue and an implant such as amesh. Specifically, the embodiments of the invention may be used forrepair of tissue defects, anastomosis of vessels or organs, suturing ofaccess sites, anchoring or fixating soft or hard tissue, fixating meshesor other implants or devices to a tissue, closing natural or artificialtissue openings, modifying anatomical spaces, lifting, stretching,pulling or retracting tissues or organs using open or minimally invasiveapproaches.

The principles and operation of the embodiments of the invention may bebetter understood with reference to the drawings and accompanyingdescriptions.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details set forth in the following description or exemplified bythe Examples. The invention is capable of other embodiments or of beingpracticed or carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein is for the purposeof description and should not be regarded as limiting.

Devices for ligating and fixating tissues which may be used viaminimally invasive approaches are well known in the art, such devicestypically utilize sutures, mechanical fasteners/anchors or a combinationthereof

A suturing system or suturing device according to embodiments of theinvention may be capable of positioning and anchoring one or moreseparated or contiguous loops of suture with or without adjustablesuture lengths and with or without adjustable suture depth through atissue while traversing the need for a tissue suturing head that spansthe tissue wall or for a curved needle capable of threading in and outof a tissue wall.

In some embodiments, a tissue suturing device may be capable ofapproximating, ligating and fixating tissues and/or implants such asmeshes and the like and may be used in both open and minimally invasivesurgeries.

Embodiments of such device may include: a rigid or flexible elongateddevice body (also referred to herein as “shaft” or “an insertiondevice”) which may be with or without a distal curved section towardsits outlet and a plurality of anchoring elements and a suture co-axiallydisposed along the shaft. As is further described herein, the anchoringelements and suture may be disposed on the shaft (e.g. in a guide railrunning along the length of the shaft) or within the shaft (e.g. in alumen running along the length of shaft). The suture may also bearranged on the shaft outlet dividing the outlet area In any case, theanchoring elements and sutures are arranged co-axially (i.e. the sutureand anchoring elements may be arranged along the length of the shaft)and preferably concentrically. The anchoring elements may be arrangedsuch that they assume the same rotational position along the shaft, oralternatively, the anchoring elements may be arranged with rotationaloffset therebetween.

As used herein, the term “suture” refers to any non-rigid elongatedelement that can be looped through a tissue. A suture may be made from athread that may be fabricated from a natural or synthetic polymer, analloy or any other bio compatible material, and may include a singlefilament or several braided or twisted filaments. The thread may be ofany diameter, shape (e.g. with edges), length and pull strength. Thethread may be permanent or degradable or mixed (partly degradable andpartly permanent) depending on the tissue sutures and the site ofsuturing. Examples of threads suitable for use with embodiments of thepresent invention may include absorbable threads that may result inabsorbable sutures fabricated from, for example, catgut, polyglycolicacid, polylactic acid, polydioxanone, or caprolactone. Non-absorbablethreads to form permanent sutures that may be used with embodiments ofthe present invention may be fabricated from, for example, silk, nylon,polypropylene, or polyester.

As used herein the phrase “ anchoring elements” (or simply anchor)refers to any element having a length which is preferably greater than adiameter thereof with a diameter suitable for delivery through a hole ina tissue (self-generated or pre-generated) and a length suitable forabutting the hole and anchoring thereagainst. As is further describedhereinunder, the anchoring elements may be configured such that it canslide on a thread or a suture and attach thereto.

Although anchoring may be provided by contact between the anchor andinner tissue wall, additional anchoring features may be used to increasesuch anchoring. For example, the anchoring element body can include aroughened surface, deployable tabs or barbs or fin or any other elementor elements that may enhance tissue fixation via adhesion, tissuepenetration or tissue pinching.

Embodiments of a device of the present invention may further include ahandle which may be attached to the proximal end of the shaft (the outertube). The handle may be permanently attached to the shaft or innertubes or removably attached thereto. The latter case may enable the useof several handle types with one shaft and/or reuse of the handle or useof one handle with several shafts.

The handle may actuate release of one or more anchoring elementsattached to a portion of a thread from the distal end of the shaft. Asis further described hereinunder, actuation of the anchoring elements-thread release mechanism (via the handle), may deliver an anchoringelement attached to a loop of thread (e.g., for forming a suture)through an opening in tissue wall. The anchoring element may abut theinternal surface of the tissue and may anchor the loop of thread throughthe tissue opening.

Embodiments of an exemplary device according to the invention may carrya single continuous strand of thread disposed co-axially (e.g.,concentrically) with a plurality of suture elements along the length ofthe shaft. Such exemplary device may be used to deliver severalcontiguous loops of the thread (while enabling adjustment of suturelength, depth and tension) without having to access both sides of thetissue. In other words, embodiments of the present device may position arunning stitch through a tissue wall by approaching a tissue surface andwithout having to access both sides of the tissue wall and/or withoutnecessitating threading of a needle in and out of tissue. Thisembodiment of the present device may particularly be advantageous incases where a surgical mesh is used in hernia defect repair and/or wherethe hernia defect is sutured. A hernia mesh is typically fixated to anabdominal wall via trans-facial suturing by looping a suture in and outof the abdominal wall. Such suturing is time consuming, associated withpostoperative pain and infections and requires a high level of skillsince the stability of the mesh depends on the quality of suturing. Postthe trans-facial fixation, the mesh is adhered to the tissue usuallywith a tacking device. The tacks protrude into the abdominal cavity andmay cause tissue adhesions. In addition, numerous tacks are needed tosecure the mesh which increases the likelihood of damaging nerve tissueand inducing postoperative pain. Tacks may not hold the tension and maydetach from the tissue specially if opposing the tissue in anon-vertical angle.

Referring now to the drawings, FIGS. 1-7F are illustrations of exemplaryapparatus for anchoring a suture in a tissue. Embodiments of apparatus10 may be configured to deliver of one or more anchoring element-threadloops through a tissue wall and can be used in minimally invasiveprocedures (endoscopic, laparoscopic) as well as open procedures.

Embodiments of apparatus 10 may include: an insertion device 12 (e.g., ashaft) having a proximal end 14 (releasable or permanently) attached toa handle 16. Device 12 may be configured to insert a thread and one ormore anchoring elements into a tissue. Apparatus 10 may further includea thread 26 and at least one anchoring element 24, both illustrated inFIG. 2. Handle 16 may house a mechanism for managing the suture and foractuating tissue piercing, anchoring element-thread delivery holding andsevering of the thread at distal end 18 of insertion device 12. Userinterface 20 of handle 16 may include controls (buttons, triggers dials)for setting the depth of tissue penetration, actuating tissue piercing,generating tension on the thread, delivering the anchoring element andattached loop of thread through the tissue and for holding and severingthe thread at the end of a suturing cycle (of one or more anchoringelements). Handle 16 is described in greater detail hereinbelow withreference to FIGS. 7A-7D.

Reference is made to FIGS. 2A-2C that are illustrations of distal end 18of apparatus 10 in greater detail. Insertion device 12 of apparatus 10may include: an outer tube 22, a thread guide tube 46, a thread 26threaded in thread guide tube 46 and at least one anchoring element 24located inside outer tube 22. In some embodiments, thread 26 may belocated outside of insertion device 12 (not threaded in the insertiondevice), such that only a small portion of the thread is guided, lead orheld by distal end 18. In the exemplary embodiment shown in FIG. 2,insertion device 12 may composed of five concentrically (and optionallycoaxially) arranged tubes with outer tube 22 housing four (or less)internal tubes. Outer tube 22 can be fabricated from an alloy or polymer(rigid or flexible) for example, stainless steel, cobalt chrome,Nitinol, PEEK (polyether ether ketone), carbon, composite material,reinforced plastics, Ceramics with a length of 5 mm-2000 mm or more.Outer tube 22 may have an outer diameter (OD) of 0.3 mm to 20.1 mm andan internal diameter (ID) of 0.25 mm to 20.05 mm. Outer tube 22 shown inFIGS. 2A-2C is cylindrical in shape and as such has a substantiallycircular cross section. However, outer tube can be provided with anyexternal cross sectional shape including rectangular, square triangularand the like as long as the lumen thereof is shaped to accommodate thetubes carried therein.

Outer tube 22 may be configured to freely accommodate guide tube 46(e.g., thread guide tube) and one or more anchoring elements 24 threadedon guide tube 46 such that each anchoring element 24 can slid alongouter tube 22 to be exit from an outlet end 38 (e.g., the distal end) ofouter tube 22. Alternatively, outer tube 22 may guide anchoring elements24. In such embodiments, device 12 does not include guide tube 46 andanchoring elements 24 may be threaded directly on thread 26. In someembodiments, the distal end 38 of outer tube 22 may have a sharpened endadapted for piercing the tissue or blunt in order to penetrate a tissuedirectly (port less delivery) or it may be blunt and deliverable througha premade tissue access site (port or port-less).

In some embodiments, at least a portion of thread 26 may be insertedinto thread guide tube 46 to be guided along the longitudinal axis ofdevice 12 and a second portion of the thread may be located external todevice 12. The connection between the first and second portions maythread an anchoring element 24 to form a suture loop. Alternatively,both the first and second portions may be inserted into device 12, suchthat only a loop of thread including anchoring element 24 may exitdevice 12 into the tissue.

Device 12 may further include a thread severing (cutting) tube 28 whichmay be positioned internally to outer tube 22. Thread severing tube 28can be fabricated from an alloy or polymer (rigid or flexible) (e.g.stainless steel, cobalt chrome, Nitinol, PEEK, carbon, compositematerial, reinforced plastics, ceramics) with a length of 5 mm to 2000mm, an outer diameter (OD) of 0.3 mm to 20.1 mm and an internal diameter(ID) of 0.25 mm to 20.05 mm.

Thread severing tube 28 may include finger-like longitudinal projections30 which are circumferentially spaced apart via cutouts 32. Projections30 may be machined or laser cut from the tube using approaches wellknown in the art. Projections 30 may widen distal to proximal and may beconfigured as sharpened blades.

A thread trapping tube 34 may be positioned inside thread severing tube28. Tube 34 can be fabricated from an alloy or polymer (e.g. stainlesssteel, cobalt chrome, Nitinol, PEEK, carbon, composite material,reinforced plastics, ceramics) with a length of 5 mm to 2000 mm, anouter diameter (OD) of 0.3 mm to 20.1 mm and an internal diameter (ID)of 0.25 mm-20.05 mm.

As is shown in FIGS. 6A-6B tube 34 may cooperate with projections 30 ofthread severing tube 28 to sever thread 26. To enable suchfunctionality, distal portion of tube 34 may include thread traps 42 fortrapping thread 26 pulled therein. Advancement of tube 34 and threadsevering tube 28 out of opening 38 (Shown in FIGS. 4I-4J) and rotationor translation of tube 34 against suture severing tube 28 (as shown byarrow in FIG. 6B) may cut the thread against a sharpened blade-likeprojection 30.

Insertion device 12 may further include a needle 36. Needle 36 may bepositioned inside tube 34 or inside outer tube 22 or severing tube 28and houses one or more anchoring elements 24 and thread 26. Theanchoring elements may be separated by guide tube 46. Needle 36 may belocated inside outer tube 22 such that a sharpened end 40 of needle 36may be in proximity to outlet end 38 of outer tube 22 and one or moreanchoring element 24 may be located inside needle 36. Needle 36 may beadvanced distally within tube 22 (via handle 16) to penetrate theabdominal wall and/or a tissue and/or mesh and deliver anchoring element24 and thread 26 therethrough. When handle 16 may be actuated, a plunger37 (shown in FIG. 7A) may move forward (distally) and move anchorelement 24 distally with or without ejection of anchoring element 24 outof needle 36. In an alternative embodiment, plunger 37 may move alongwith needle 36 and actuation of handle 16 retracts tissue piercing tube36 to eject anchor 24.

In some embodiments, needle 36 may include at least one elongated slit39 substantially parallel to the needle's central axis. The elongatedslit (illustrated in FIGS. 2B and 2C) may be used to guide a fin elementincluded in anchoring element 24. The slit 39 may be ended towards theshaft outlet 38 or at the shaft outlet. The fin element may protrudeover the slit. The fin element is discussed in detailed below withrespect to FIG. 31.

Needle 36 may be fabricated from an alloy or polymer (e.g. stainlesssteel, cobalt chrome, Nitinol, PEEK, carbon, composite material,reinforced plastics, ceramics) with a length of 5 mm to 2000 mm an outerdiameter (OD) of 0.25 mm to 20.05 mm and an internal diameter (ID) of0.2 mm to 20 mm. Needle end 40 can be double beveled or pointed. Needleend 40 proximal part may be blunt for not cutting the thread. Plunger 37can be fabricated from similar materials and lengths with an OD slightlysmaller than an ID of tissue piercing tube 36.

The lumen of a distal end portion 40 of needle 36 may be configured toensure that anchoring element 24 may tilted (with respect to thelongitudinal axis of needle 36) when pushed out of needle 36 (viaplunger 27 or by another embodiment via advancing assemble 45). Needleend 40 angle may enable the ejection of anchor element 24 tilted byforming an angle with respect to needle's 36 longitudinal axis. Forexample, the lumen of tube 36 can include a bump or ‘ramp’ or shapedwith an angle to initiate tilt of anchor 24 as it exits the distal endof tube 36.

It will be appreciated that the tissue piercing function of needle 36may also be provided by anchoring element 24 and/or outer tube 22. Insome embodiments, anchoring element 24 may include a sharpened end forpiercing the tissue at at least one of the anchoring element. Asanchoring element 24 may be advanced within tube 22, a sharpened endthereof can be carried through the tissue by tube 22 and provide thethrough tissue path for tube 22 (and anchoring element 24 and thread 26carried thereby).

Guide tube 46 may be fabricated from an alloy or polymer (e.g. stainlesssteel, cobalt chrome, Nitinol, PEEK, carbon, composite material,reinforced plastics, ceramics) and optionally coated (e.g. Teflon©) toenable smooth feeding of thread 26 into tube 46 therein and threadinganchoring element 24 thereupon. Guide tube 46 may have a length of 5 mmto 2000 mm, an outer diameter (OD) of 0.1 mm to 20 mm and an internaldiameter (ID) of 0 to 20 mm.

Guide tube 46 may serve to facilitate sliding of anchoring elements 24thereupon and thread 26 therein. An anchoring element 24 threadsdirectly over thread 26 once it is advanced off of tube 46.

Although guide tube 46 may be shown with a circular cross section, itwill be appreciated that a guide tube 46 with a non-circular crosssection (e.g. oval, square) can also be used herein. Use of such a guidetube 46 in device 12 included in apparatrus 10 may be advantageous sinceit may be used to guide anchoring elements 24 (of similar crosssectional shape) in a predefined rotational direction thus ensuring thatall anchors 24 exit tube 36 in the same rotational direction.

In some embodiments, insertion device 12 included in apparatus 10 mayfurther include an advancing assembly 45, illustrated in FIGS. 2B-2C,for advancing one or more anchoring elements 24 along outer tube 22towards the outlet end 38 of outer tube 22. In some embodiments,advancing_assembly 45 may further be configured to cause anchoringelement 24 exiting outer tube 22 from outlet end 38 to tilt in thetissue relative to the direction of longitudinal axis of outer tube 22.Advancing mechanism 45 may include a tilting mechanism 47 located inproximity to outlet end 38. Tilting mechanism 47 may include anelongated flexible pusher 49 to push anchoring element 26. Pusher 49 maybe inserted via slit 39 of needle 36, thus bending while advancingelement 26, causing element 26 to tilt. The tilting may start alreadywhile anchor is entering the proximal part of the needle sharp end 40and continue after exiting the needle. For example, pusher 49 may beinserted into an edge or a fin element included in anchoring element 24.Advancing mechanism 45 may cause advancing of each anchoring elementseparately. Alternatively, advancing mechanism 45 may cause advancing ofa plurality of anchoring elements simultaneously. Detailed disclosure ofthe tilting mechanism is given with respect to FIGS. 10E-10G. Advancingmechanism 45 may be operated and activated activating a trigger or bypushing a button in user interface 20 included in handle 16. Advancingmechanism distal end may have various shapes. In some embodiments,advancing mechanism 45 may push an anchor element 24 distally into thetissue more distant from the needle end, generating an axial distantfrom the anchor proximal end and the needle distal end causing theanchor to channel its own rout in the tissue.

In some embodiments, part or all of the tilting may occur while anchorelement 24 progresses distally in the tissue while radial forces areapplied causing the anchor element 24 to progress distally in a curvedrout after the thread 26 is locked on the anchor 24 (pendulum effect)and/or when the advancing mechanism 45 pushes the anchor in the tissuein a curved rout and/or when suture arm or arms 52 may be pulleddistally.

In some embodiment, locking of anchor element 24 in the tissue may beenhanced by the anchor rout or traveling. The needle 36 may penetratethe tissue wall axially. Anchor element 24 may be actuated by the handle16 progress distally while in the needle 36. Once exiting needle 36 withor without tilted position, anchor 24 may progress in a curved out.Thus, tubes 22, 28, 34, needle 36, mechanism 45 and tube 46 provide thefollowing functionality to insertion device 12 and the device may bemanufactured with or without each of the following components:

(i) Outer tube 22 may support internal tubes 28, 34, needle 36 and 46; adistal end 38 thereof may be positionable against a tissue wall toenable device actuation in position and holding the thread against themesh or tissue surface; outer tube 22 may be fixed in position.

(ii) Needle 36 may pierce through a tissue wall when advanced distallyfrom handle 16 to enter the abdominal cavity or to deliver anchoringelement 24 and thread 26 through the tissue. Advancing mechanism 45 mayadvance anchoring element 24 along needle 36 and/or outer tube 22.Sharpened end 40 of needle 36 is extendable out of opening 38 apredetermined distance as set by handle 16.

(iii) Tube 34 may hold thread 26 to enable a new anchoring element 24delivering cycle over the suture. Thread severing tube 28 and tube 34may cooperate to sever thread 26 and enable thread severing and holdingprior to delivery of one or more anchoring elements 24; both tubes mayadvance out of tube 22; tube 34 with captured thread end may be alignedwith, and rotated (or optionally translated) within tube 28 to seversuture.

(iv) Guide tube 46 serves to facilitate smooth advancement of bothanchoring element 24 and thread 26.

As is mentioned herein, apparatus 10 and insertion device 12 may be usedto deliver one or more anchoring element-thread loops through a tissue.Some exemplary embodiments of anchoring elements 24 with and withoutattached loop of thread 26 are shown in FIGS. 3A-3G.

An anchoring element according to embodiments of the invention may beanchored in the tissue and may further include a thread locking elementwhich may lock thread 26 during or after insertion of the anchoringelement to the tissue. A plurality of such anchoring elements may beconsecutively inserted into the tissue to anchor and generate a runningsuture. Embodiments of anchoring element 24 may include a centralelongated body 23 adapted to be threaded on a thread 26 and a lockingelement such as for example, at least one recess 50. Additional lockingelement different from recess 50 is discussed with respect to FIG. 3D.The locking element may be configured to lock thread 26 on anchoringelement 24 during insertion of the anchor element. In some embodiments,recess 50 may have a wide end 51 and a narrow end 53. Narrow end 53 maygrip thread 26 during anchoring. In some embodiments, anchoring element24 may include a central elongated body 23 adapted to be threaded on athread 26 and having a locking element, such as at least one of recess50, slit, or the like.

Central elongated body 23 may substantially a hollow cylinder or tubeand includes at least one, preferably 2 or 4 or more recesses 50 fortrapping two ‘arms’ 52 of a suture loop 54 therein. Recesses 50 mayinclude a tapered or sawtooth configuration or preferably, a slightlytapering rectangular shape having a wide end 51 and a narrow end 53 asis shown in FIG. 3C. Anchoring element 24 end portions may terminate ina blunt or sharpened end (for penetrating through tissue as describedabove). Anchoring element 24 may be fabricated from a biocompatiblealloy or polymer such as PEEK or Absorbable Polymer (PGA, PLA PLGA) orthe like. Anchoring element 24 may be biodegradable or not depending onuse.

Alternative configurations of anchoring element 24 may utilize anythread-trapping elements which are ‘activated’ prior to release ofanchoring element into tissue. Such configurations may include, forexample, an element fabricated from a shape memory alloy (such asNitinol) or any other elastic material (e.g. elastic polymer) that maybe linearized when anchoring element 24 may positioned (threaded) onguide tube 46 and folds to form a shape that traps and engages thread 26once released from guide tube 46. For example, FIG. 3D illustrates ananchoring element 24 which may include an exemplary locking element inthe form of one or more deformable tabs 25 which deform inward to trapthread 26 once anchoring element 24 may be released from device 12. Tabs25 may be maintained linear with anchoring element 24 body whenanchoring element 24 may be positioned on tube 46 within insertiondevice 12. When released, anchoring element 24 may slide off tube 46 andtabs 25 bend inward to the position shown in FIG. 3D.

In any case, anchoring element 24 may be configured such that it iscapable of sliding on thread 26 within outer tube 22 and lockingthereagainst when delivered out of the distal end of apparatus 10.

As anchoring element 24 may slide off tube 46 (when anchor 24 advanceddistally along suture 26 via handle 16), anchoring element 24 may threaddirectly over thread 26. Release of anchoring element 24 (threaded ornot threaded over thread 26) on a far side of a tissue wall (from needletube 36), may cause rotation and trapping (angular movement) ofanchoring element 24. When suture arms 52 may be pulled againstanchoring element 24 (abutting it against the far side of the deliveryhole), suture arms 52 may slide into longitudinal recess 50 and aretrapped therein thus forming the T-bar like configuration shown in FIGS.3A-3B. As is further described herein below with respect to FIGS. 4A-4J,this formed T-bar like configuration may enables an anchoring 24delivered through a tissue wall to abut the far side of the tissue holewith the suture arms positioned through the tissue hole.

Additional exemplary anchoring elements 24E-24H are shown in FIGS. 3E-3Hrespectively. FIGS. 3E-3G are isometric illustrations of exemplaryanchoring elements 24E-24G according to some embodiments of theinvention. Embodiments of anchoring elements 24E-24F of FIGS. 3E and 3Fmay include central elongated body 23 having a form of a tube. In FIG.3E two recesses 50 are located on two opposite peripheral sides (e.g.,above and below) of the tubular body. Recesses 50 in FIG. 3E and also3A-3D have wide end 51 of each recess 50 coincides with an end of theelongated body. In the embodiments of FIGS. 3A-3D length of each recess50 may be shorter than half the length of the elongated body and/or thetwo recesses 50 may be symmetrically located from two ends of theelongated body. Embodiments of anchoring element 24F illustrated in FIG.3f may include only one closed recess 50. Embodiments of anchoringelement 24G of FIG. 3G may include an elongated body having a “springshape”. Such an element may or may not be configured to compress wheninserted into outer tube 22 and extend when exit end 38 of insertiondevice 12. Element 24G of FIG. 3g may extend while anchoring threads 26in the tissue, to further enhance the anchoring of the suture. In theexemplary embodiments of FIGS. 3A-3E and 3 g two recesses 50 may havesubstantially the same shape. Alternatively, each of the two recessesmay have a different shape. Anchoring elements 24E and 24G may not bethreaded on guide tube 46 or thread 26 while in the insertion device 12.The locking of anchor elements 24E and 24G may occur when exiting thedistal end 18 while thread 26 may be located in a contour shape on outertube 22 outlet 38.

In some embodiments, anchoring elements 24, 24E-24F and 24H may furtherinclude a fin element 55, illustrated in FIGS. 3E-3F and 3H. Fin element55 may have several functionalities. Fin 55 may by attached to advancingmechanism 45, such that elongated pusher 49 may push fin element 55 thuscausing elements 24E-24F and 24H to advance forwarded in outer tube 22.Fin element 55 may slide inside elongated slit 39 in needle 36 (or aslit in any other tube included in device 12), thus ensuring thatelement 24 may always have the same orientation (prohibiting element 24from rotating inside tube 22 or needle 36). When pushed out of insertiondevice 12, fin 55 may assist element 24 to tilt inside the tissue andavoid slipping back out of the tissue.

In some embodiments, fin element 55 illustrated in FIG. 3H may form anangle a (e.g., 90° or less) with the central elongated body 23 ofanchoring elements 24. In some embodiments, fin element 55 mayelastically bend towards the central elongated body (the bending mayeither have plastic or elastic features), for example when inserted intoouter tube 22 or needle 36. In some embodiment the fin element 55 may berigid. In some embodiments, anchoring element 24H may be threaded onguide tube 49 or guided otherwise inside insertion device 12. Asanchoring element 24H may be positioned inside insertion device 12 asharp angle a formed by fin elements 55 of anchoring element 24 H may befacing inlet end (proximal portion) 14 (illustrated in FIG. 1) of outertube 22 opposite to outlet end (distal portion) 18.

Reference is now made to FIG. 31 which is an illustration of ananchoring element according to some embodiments of the invention. Ananchoring element 24I may include an elongated body 23 and a fin 55. Fin55 may be configured to be lift up for sliding inside a slit in one ofthe tubes included in insertion device 12. Anchoring element 24I mayhave a proximal space past the fin to allow advancing assembly 45 tohold anchoring element 24I better on guide tube 34 and avoid itsunwanted movements forward. This arrangement may stop anchoring element24 from unintentionally (e.g., without being pushed) advancing furtheron the guide tube and to avoid accidental pushing of the element by theadvancing assembly in the anchor's proximal part and not under the fin55. Additionally, this configuration may further cause a better slidingof the anchoring element while keeping the fin open.

Embodiments of apparatus 10 may include a plurality of anchoring element24 aligned in an insertion device 12, for example, in outer tube 22 orneedle 36. Each of the anchoring elements may include locking element(e.g., a recess or a tab) to lock a thread 26. Insertion device 12 maybe designed such that thread 26 may move freely within insertion device12. After the insertion of anchoring elements 24 to a tissue eachanchoring element may lock a portion of the thread to form a sutureloop.

Anchor element 24 may have a locking element to lock the thread duringor after the ejection of the anchor element. On one embodiment, the lockmay occur while anchoring element 24 is pushed distally over the guidetube 46 or towards the shaft outlet end 38 or when suture arm or arms 52are pulled to cause a tension

FIGS. 4A-4J illustrate delivery of a single anchoring element 24 (withattached thread 26) from distal end 18 of apparatus 10.

Insertion device 12 may be positioned against the tissue therebyapparatus 10 in position. Actuation of handle 16 (or any other releasingdevice) may push (a pre-defined distance or several pre-defineddistances) needle 36, plunger 37, (FIG. 7A) and/or advancing mechanism45 (illustrated in FIG. 10) thus causing advancing mechanism 45 to pushat least one anchor element 24 over the guide tube 46 and onto thethread; needle 36 (or alternatively, anchoring element 24 and/or outertube 22 having sharpened end) may penetrate the tissue to a predefineddepth. The same or a second actuation of handle 16 may push plunger 37to advance anchor element 24 towards the distal end or needle 36 orouter shaft outlet 18 and push advancing assembly 45 to releaseanchoring element 24 from needle 36 and into the tissue. The thread maybe tensioned and trapped against anchoring element 24 which may in turnrotated (e.g., tilt and curved rout) and trapped against the innertissue surface. Thread 26 may be anchored in narrow side 53 of at leastone recess 50. Handle 16 may be actuated again to distally push tube 34thereby trapping thread 26 in slots 42 and to advance and/or rotate tube28 thereby cutting thread 26. Alternatively, thread 26 can be severedand/or held using scissors and/or grasper thereby omitting the need fortubes 28 and 34.

Delivery of anchoring element 24 via the mechanism as described above isgiven as an example only, however, it will be appreciated thatalternative delivery approaches which include rotation (torqueing) ofanchoring element 24 into tissue or firing of anchoring element 24 intothe tissue via, for example, a spring loaded firing mechanism are alsocontemplated herein.

FIG. 5A illustrate a continuous suture (running stitch) composed of fivecontiguous anchoring element-thread loops positioned using for example,apparatus 10, by repeating the steps outlined in FIGS. 4A-4H describedabove five times along a tissue 60. Each of the thread loops illustratedin FIG. 5A may be adjusted with different suture loop width or suturedepth in the tissue. The arrows point at tissue holes 62 formed byneedle 36. FIG. 5B is a magnified view of one anchoring element-threadloop. The thread length may be adjusted by the user based on tissuedepth and tightness as well as distance between delivered anchor-sutureloop. Anchoring elements 24 may abut in the tissue in any rotationalorientation with the length of anchoring element 24 parallel to thetissue surface. Penetration into the tissue may be perpendicular or atany desired angle as long as anchoring element 24 may penetrate throughthe tissue wall and may be entrapped against its distal surface in anyrotational angle.

FIG. 5C illustrates an example of a degradable (e.g. bio-absorbable)anchoring element 24 or semi degradable anchoring element 24 (fabricatedfrom degradable and non-degradable portions) connected to a suture loopwithin tissue 60. Once anchoring element 24 degrades (partialdegradation shown), the thread loop may maintain the shape and positionshown due to tissue fibrosis around thread arms 52 and anchoring element24 as well as fibrosis of tissue access site 62. Thus, followingcomplete absorption of anchoring element 24, thread 26 may still providethe requisite fixation strength. In the case of a semi-degradableanchor, the non-degradable portion may further strengthen suture loopanchoring within tissue.

Following delivery of the anchor-suture loops, thread 26 can be cut asis illustrated in FIGS. 41-4J and 6A-6B or by external scissors. Anynumber of anchoring element-thread loops (e.g. 1-100) may be placedthrough a tissue wall. Thread ends of a single anchor or a series ofanchors may be tied or left untied.

As is mentioned hereinabove, actuation of tubes 28, 34, needle 36 andmanagement of suture 26 may be effected via a mechanism disposed inhandle 16.

FIGS. 7A-7D illustrate an exemplary embodiment of an exemplary mechanism70 which may be suitable for use with apparatus 10.

Actuation of trigger 70 may advance assembly 71 with respect tonon-movable device 12 to pierce the tissue via needle 36 as is shown inFIGS. 4A-4B. The movement of assembly 71 may include simultaneousmovements of assembly parts, device 12 does not move.

Spring 72 may be compressed as a result of forward movement of assembly71. Actuation of trigger 73 may deliver an anchor-suture loop by pullinglever 79 that in turn may pull rack 75. One of the teeth in rack 75 maypush leaf spring 77 distally which in turn may push element 76 (FIG.7B). This may cause leaf spring 78 to skip a tooth of the serrated innersurface of assembly 71. This may prevent element 76 from going backwardswhen trigger 73 is released thus keeping the pusher in place and first(distal) anchor aligned with the distal end of tissue piercing tube 36.Actuation of trigger 73 may also compress spring 74 which may expandwhen trigger 73 is released to return rack 75 to its starting positionwith leaf spring 77 skipping a tooth in rack 75.

Release of trigger 70 may return apparatus 10 to its initial position toenable another cycle of tissue piercing and delivery of anchor-suture.

As is mentioned herein, apparatus 10 of the present invention can beused to fixate an implant to a tissue wall in a procedure such as herniarepair.

Laparoscopic hernia repair is an intra-abdominal, intraperitoneal repairthat utilizes a mesh prosthesis to secure and cover a hernial defect;the hernia defect itself is usually not closed, though there are caseswhere the defect is suture or its contour is reduced. Traditionally, themesh is anchored and held in position with trans-facial mattress sutures(2-0 or 0) provided at each corner of the repair. Typically, fourmattress sutures are used, but for larger repairs eight or more mattresssutures are placed at 5 to 6 cm intervals. The sutures are tiedsubcutaneously through a small stab incision in the skin. In between themattress sutures, the mesh is tacked or stapled to the abdominal wallfascia at 1 cm intervals with special hernia staples or spiral tacks.

In some embodiments, apparatus 10 may be used to repair an abdominalhernia as follows. A cannula may be positioned several centimeters awayfrom the nearest border of the hernia, preferably at the midline.Pneumoperitoneum may be established and an angled (30 or 45 degrees)laparoscope may be inserted to facilitate insertion of the othertrocars. A single 5 mm or 10 mm trocar and optionally one or two 5 mmtrocars or one or two three mm ports or percutaneous micro-laparoscopytools may be positioned through the abdominal wall as far laterally aspossible from the hernia. Next, grasping forceps and scissors may beused to reduce the hernia, and outline the defect in the fascia. Foroptimal exposure, the working ports may be positioned as far away fromthe hernia defect as possible. Since the mesh may overlap the defect by3 to 4 cm, a very lateral or inferior position of the trocar sitemaximizes the view and efficiency of the procedure when the mesh isunrolled and deployed. Device 10 may be used to suture the defect or toreduce circumference of the defect.

The edge of the defect may be identified and marked on the skin and apiece of appropriately sized and tailored mesh prosthesis (with 3 to 5cm cuff or margin lateral to the fascia defect in all directions) may beprepared and marked. The corners of the mesh may be marked to maintainthe proper orientation when the mesh is sutured in place. The mesh maybe inserted into the abdomen. The device 12 of apparatus 10 may belocated above the hernia defect (outside the abdominal cavity) and maydeliver at least one anchoring element 24 from the outside of theabdomen inside, passing the abdominal wall and the mesh. Fixating and/oradhering the mesh center and/or corners to the abdominal wall (from theinside) and in the right location where the hernia defect may be abovethe center of the mesh. At the end of the procedure, anchoring element24 may be left behind or removed once the mesh is adhered and fixated.The apparatus 10 may be delivered preferably through a 10-5 mm port or a2-3 mm incision or puncture (port-less) depending on the size andlocation of the hernia. The first corner of the mesh may be held using agrasper against the corner of the ventral defect. The distal tip of thepresent device may be pushed against the grasped mesh to penetrate themesh and the tissue to a depth of 3-20 mm, depending on the thickness ofthe abdomen. Next, an anchoring element 24 may be delivered into thetissue as is described hereinabove. Apparatus 10 may then be pulled backto tension the suture, lock it more firmly into the anchor and applyadditional rotation to the anchor into its final position against thedistal surface of the abdominal wall.

Apparatus 10 distal tip may be moved to the next desired location forfixation along with the extended length of suture and the suturing stepmay be repeated. Typically, 1-4 anchors may be deployed from the presentdevice at each corner of the mesh (connecting thread may be left or cutafter final fixation). Alternatively, the corner fixation may beperformed with 2 or more consecutive anchor elements at each corner andthe thread may be severed once moving from corner to corner. Once cornerfixation is completed, the mesh is further fixated to the abdominal wallusing apparatus 10 or standard approaches such as double crown or thelike. Alternatively, the mesh may be initially fixated at its fourcorners via standard trans-fasciae sutures or tacks and apparatus 10 maybe used to perform additional fixation via single or running stiches.Alternatively, the suturing can be performed without fixation of thecorners. The fixation of the mesh and advancing with the mesh fixationmay be performed in any routinely order with one or more single orcontinuous stiches. Following fixation, the present device is removedfrom the abdomen and the access sites may be closed using apparatus 10or any other approach known in the art.

Thus, the present invention may provide a tissue suturing device whichmay be used to approximate ligate and/or fixate tissue via open orminimally invasive procedures. Apparatus 10 may be used in ventral,umbilical, inguinal, or hiatal hernia repair, fundoplication, bariatricsurgery via gastric sleeve, rectopexy and mesh or mesh-less assistedpelvic organ prolapse fixation, hysterectomy, myomectomy,abdominoplasty, mammopexy, rhytidectomy, meniscus repair or rotatorscuff repair access site closure or any procedure which requires tissueto tissue or tissue to implant approximation/fixation ortissue/organ/device/implant lifting or holding or retracting.

Insertion device 12 of apparatus 10 may include a distal marker toensure that the outer tube does not penetrate into the tissue, whileneedle 36 may include graduation marks to determine manual or one ormore predefined depth of penetration. Additional markers may bepositioned on outer tube 22 or tube 24 to enable visualization throughimaging modalities or camera or to ensure that the device does notpenetrate into the external tissue (e.g. the abdominal wall). Additionalmarkers may be positioned on handle 16 indication the number of anchorelements 24 left in device 10.

The invention may provide several distinct advantages over currentlyavailable tissue suture/ligation/fixation approaches:

(i) the apparatus 10 may be used to produce a single tissue fixationpoint or multiple contiguous fixation points easily and rapidly with noneed for additional knot tying in any type of tissue including a bone;

(ii) tissue/implant is sutured/fixated/ligated via a thread therebyproviding a robust and reliable connection;

(iii) delivery of a suture loop may do not require access to the farside of a tissue wall;

(iv) delivery of suture may be adjusted for tissue thickness on the fly,enabling continuous suturing of varying thickness tissues;

(v) force of ligation may evenly distribute between contiguous sutureloops thereby minimizing the likelihood of tissue ischemia;

(vi) apparatus 10 may be used with permanent thread/anchoring element orbiodegradable thread and/or anchoring element;

(vii) apparatus 10 may penetrate the tissue vertically or at anyselected angle;

(viii) the anchoring element may not protrude above surface minimizingtissue adherence or perforations;

(ix) the suture covers more surface thus reducing the numbertacks/anchoring elements/sutures needed and the risk of damaging tissuesuch as blood vessels, nerves etc.;

(x) apparatus 10 may be used with a mini-port or delivered directlythrough the tissue (port-less) thus reducing the risk of infections andscarring;

(xi) apparatus 10 insertion device may be flexible and articulated andthus the device working head (tip) may be easily positioned withinanatomically confined spaces;

(xii) apparatus 10 may be delivered over a guide wire positioned withinvascular tissue; and

(xiii) apparatus 10 may be used with a robotic surgical system which mayactuate the device 10.

FIGS. 7E-7F illustrate embodiments of apparatus 10 having a flexible(FIG. 7E) or deflectable (FIG. 7F) insertion device 12 or curved towardsshaft distal end 18. Such apparatus 10 configurations can be used inendoscopic or laparoscopic procedures. The tubes of flexible device 12may be fabricated from an alloy or a polymer and may be elastically orplastically bendable. Device 12 may be constructed from a series ofinterconnected links or from a slotted tube(s). Control wires may runthe length of the shaft and enable deflection of device 12 from thehandle. Apparatus 10 may also include more than one devices 12 attachedto a single handle 16. For example, a dual device 12 operable via asingle handle 16 mechanism may be used to lay down a double suture linewith simultaneously delivery of two anchoring elements a predetermineddistance from each other. The devices may run parallel to each other orat a converged/divergent angle. In such a multi insertion deviceconfiguration, anchoring elements 24 can be connected in pairs, enablingrelease of one thread loop attached to two anchoring elements with everycycle. In such a configuration, the pair of anchors may be connected andthe thread trapping mechanism following release may be optional.

Apparatus 10 may be fabricated using approaches well known in the art.For example, insertion device 12 and the tubes contained therein can beextruded or rolled from an alloy, while handle 16 can be fabricated frominjection molded and machined components.

As used herein the term “about” refers to ±10%.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following examples, which are not intended to belimiting.

EXAMPLES

Reference is now made to the following examples, which together with theabove descriptions, illustrate the invention in a non-limiting fashion.

Example 1 Prototype Bench Testing 1

Initial experiments were performed with a prototype that includes theanchoring elements 24, threads 26and insertion device 12 in order todetermine feasibility of delivering an anchored suture through excisedtissue. A 0.8 mm O.D. hollow alloy 8 mm in length was curved at the tipsto form a groove for locking the suture. The tube was also tapered atthe ends to facilitate penetration through a tissue access site. Tenindividual anchoring elements were threaded over a 2-0 silk thread andthe thread with threaded anchors was inserted into a 10 cm long hollowneedle with a sharp tapered distal end capable of tissue piercing. A rodwas fitted into the needle through the proximal end to serve as aplunger for expulsion of a suture anchor.

A standard 4×4 cm poly-propylene mesh was used along with a 20×20 cmpiece of bovine abdominal muscle as the tissue model. The mesh wasplaced over the tissue and the needle was inserted through the mesh andinto the tissue (to a depth of about 3 cm). The plunger was thenadvanced within the needle (about 1 cm) thereby pushing one anchoringelement out of the needle and into the tissue. The pusher and needlewere retracted out of the tissue, leaving a loop of thread and athreaded anchoring element over it, in the tissue. The process ofanchoring element-thread delivery was repeated several times.

Example 2 Prototype Bench Testing 2

A second prototype including handle was fabricated by 3D printing thehandle and actuating mechanism and attaching it to concentricallyarranged tubes (FIG. 8A). The prototype was tested by sequentiallydelivering several anchoring elements through a 3 cm thick foam boardforming a running stitch (FIG. 8B-8C). The prototype was then used todeliver two anchoring elements (each with attached suture loop) throughfascia of excised bovine muscle tissue to simulate fascia anchoring(FIG. 9A). The load capacity of a single anchor point exceeded 600 grams(FIG. 9B).

Reference is now made to FIGS. 10A-10H which are illustrations ofapparatus 10 in several positions illustrating 8 steps in the insertionand/or delivery of a single anchoring element 24 using insertion device12. FIGS. 10A-10H shows the advancing and positioning of the variouselements of apparatus 10 (with respect to each other), discussed anddisclosed above during the insertion of insertion device 12 and thedelivery of anchoring element 24 and thread 26 into the tissue. Duringthe insertion of anchoring element 24 by insertion device 12, element 24may exit in tilt position from needle sharp end 40 and continue to tiltin the tissue as illustrated in FIGS. 10E-10H and discussed below withrespect to the method of FIG. 12. FIGS. 11A-11B are illustrations ofdevice 12 in two positions of performing delivery of a first anchoringelement from a plurality of anchoring element inserted into device 12.

Reference is made now to FIG. 12 which is a flowchart of a method ofsuturing a tissue according to some embodiments of the invention. Instep 122, method according to embodiments of the present invention mayinclude piercing the tissue while inserting to the tissue an apparatusfor suturing, for example, apparatus 10. Apparatus 10 may include anouter tube 22, a thread 26 at least partially inserted inside outer tube22 and at least one anchoring element 24. In some embodiments, apparatus10 may further include needle 36 for piecing the tissue. In order topierce the tissue needle 36 may be extend beyond end 38 of outer tube22. Needle 36 sharpened end 40 may pierce the tissue, as illustrated inFIGS. 10A-10C. Alternatively, outer tube 22, guide tube 46 or anchoringelement 24 may have a sharpened end for piercing the tissue.

In step 124, embodiments of the method may include advancing at leastone anchoring element 24 towards outlet end 38 of outer tube 22 to causeat least one anchoring element 24 to exit from outlet end 38 of outertube 22 into the tissue such that at least one anchoring element 24 isanchored in the tissue and threaded on thread 26, as illustrated inFigs.10E-10F. In an exemplary embodiment, advancing mechanism 45 maypush fin element 55 of anchoring element 24 along the longitudinal axisof insertion device 12. As illustrated in FIGS. 11A-11B a plurality ofanchoring elements may be inserted into insertion device 12 one afterthe other. Advancing mechanism (e.g., pusher 49) may push each ofelements 24 separately, for example, by pushing fin element 55.Alternatively, advancing mechanism 45 may advance two or more anchoringelements simultaneously.

Fin element 55 of each anchoring element 24 may slide inside anelongated slit included in one of the elongated components of insertiondevice 12. For example, fin element 55 may slide in slit 39 included inneedle 36 (as illustrated in FIGS. 10A-10H). Alternatively, fine element55 may slide inside a slit formed on outer tube 22, trapping tube 34,cutting tube 28 or guiding tube 46 (illustrated in FIGS. 2A-2C).

In some embodiments, advancing at least one anchoring element 24 towardsoutlet end 38 may include tilting at least one anchoring element 24 uponexiting outer tube 22, with respect to the longitudinal axis of outertube 22. As can be seen in FIGS. 10E-10F, pusher 49 may be flexible andmay bend when exiting from end 38 via slit 39 in needle 36. This bendingmay cause or help anchoring element 24 to tilt inside the tissue. Insome embodiments, anchoring element 24 may continue to tilt in thetissue and advance in a curved rout after exiting insertion device 12.Additional tilting may be caused by pulling the portion of thread arm52. In some embodiments, when tilted anchoring element 24 may move in acurved rout in the tissue.

In step 126, the method may include causing thread 26 to be gripped bythe locking element, for example, at narrow end 53 of recess 50, or bytabs 25 included in anchoring element 24, as illustrated in FIGS. 3A-3B.In some embodiments, anchoring element 24 may include at least onerecess 50 and thus, when manipulating thread 26 may cause thread to begripped at narrow end 51 of recess 50 of the anchoring element.

Handle 16 may activate advancing mechanism 45 by, for example, pushing abutton or a trigger in user interface 20.

In some embodiments, the method may include pulling apparatus 10, bypulling insertion device 12, from the tissue such that thread 24 may beanchored in the tissue by at least one anchoring element 24, as shown inthe photographs of FIGS. 8B and 9A.

In some embodiments, the method may further include causing anchorelement 24 to be anchored in the tissue, for example, by puling thread26.

In step 128, the method may include repeating operation 122-126, to forma plurality of sutures, also known in the art as running stich. Such anembodiment was disclosed above with respect to FIG. 5A.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable sub-combination.

While certain features of the invention have been illustrated anddescribed herein, many modifications, substitutions, changes, andequivalents will now occur to those of ordinary skill in the art. It is,therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the invention.

What is claimed is:
 1. An apparatus for suturing tissue, comprising: (a)an elongated shaft; (b) a needle disposed inside said elongated shaftsuch that a sharp end of the needle is in proximity to a distal end ofsaid elongated shaft, wherein said needle is advanceable distally withinsaid elongated shaft, to penetrate the tissue; (c) a handle disposed ata proximal end of said elongated shaft; (d) a thread disposed along thelength of said elongated shaft; (e) multiple anchoring elements:disposed inside said needle, along the length of said needle, threadedon said thread, and each of said anchoring elements comprising: atubular elongated body through which said thread is threaded, and a finconfigured to extend away from said body at a sharp angle with respectto said body, wherein said fin is configured at least to prevent theanchoring element from slipping back, out of the tissue; and (f) anelongated flexible pusher disposed inside said elongated shaft and beingtriggerable by said handle, wherein said elongated flexible pusher isconfigured to: bend after exiting the distal end of said elongatedshaft, and consecutively push the fin of each of said anchoring elementsuntil the respective anchoring element is ejected out of the distal endof said elongated shaft and implanted into the tissue, wherein thebending of said elongated flexible pusher and the pushing of therespective fin cause the respective anchoring element to travel in acurved route through the tissue.
 2. The apparatus according to claim 1,wherein said elongated flexible pusher is further configured to push therespective fin to create a distance between the respective anchoringelement and the distal end of said elongated shaft which is greater thana length of the tubular elongated body of the respective anchoringelement.
 3. The apparatus according to claim 2, wherein the distance isgreater than twice the length of the tubular elongated body of therespective anchoring element.
 4. The apparatus according to claim 2,wherein said thread is freely accommodated inside said multipleanchoring elements, such that said multiple anchoring elements can slidealong the length of said elongated shaft.
 5. The apparatus according toclaim 2, wherein said handle comprises a control for setting a depth oftissue penetration by said needle.
 6. The apparatus according to claim2, wherein said handle comprises a control for generating tension onsaid thread.
 7. The apparatus according to claim 2, wherein said handlecomprises a control for severing said thread at the end of a suturingcycle.
 8. The apparatus according to claim 7, further comprising athread severing tube and a thread trapping tube that are disposed insidesaid elongated shaft and are configured to cut said thread by rotation.9. The apparatus according to claim 2, wherein each of said multipleanchoring elements is made of an alloy.
 10. A method for suturingtissue, comprising: providing an apparatus that comprises: (a) anelongated shaft, (b) a needle disposed inside said elongated shaft suchthat a sharp end of the needle is in proximity to a distal end of saidelongated shaft, (c) a handle disposed at a proximal end of saidelongated shaft, (d) a thread disposed along the length of saidelongated shaft, (e) multiple anchoring elements: (i) disposed insidesaid needle, along the length of said needle, (ii) threaded on saidthread, and (iii) each of said anchoring elements comprising: a tubularelongated body through which said thread is threaded, and a finconfigured to extend away from said body at a sharp angle with respectto said body, and (f) an elongated flexible pusher disposed inside saidelongated shaft; and operating said handle to: (g) advance said needledistally within said elongated shaft, to penetrate the tissue with saidsharp end of said needle, and (h) advance said elongated flexible pusherdistally within said elongated shaft, such that a distal end of saidelongated flexible pusher pushes the fin of a respective one of saidanchoring elements until the respective anchoring element is ejected outof the distal end of said elongated shaft and implanted into the tissue,wherein, when the distal end of said elongated flexible pusher pushesthe fin, the elongated flexible pusher bends and causes the respectiveanchoring element to travel in a curved route through the tissue. 11.The method according to claim 10, wherein the pushing by elongatedflexible pusher comprises creating a distance between the respectiveanchoring element and the distal end of said elongated shaft which isgreater than a length of the tubular elongated body of the respectiveanchoring element.
 12. The method according to claim 11, wherein thedistance is greater than twice the length of the tubular elongated bodyof the respective anchoring element.
 13. The method according to claim11, wherein said thread is freely accommodated inside said multipleanchoring elements, such that said multiple anchoring elements can slidealong the length of said elongated shaft.
 14. The method according toclaim 11, further comprising operating a control in said handle forsetting a depth of tissue penetration by said needle.
 15. The methodaccording to claim 11, further comprising operating a control in saidhandle for generating tension on said thread.
 16. The method accordingto claim 11, further comprising operating a control in said handle forsevering said thread at the end of a suturing cycle.
 17. The methodaccording to claim 16, further comprising operating a thread severingtube and a thread trapping tube that are disposed inside said elongatedshaft, to cut said thread by rotation.
 18. The method according to claim11, wherein each of said multiple anchoring elements is made of analloy.